Quality Assurance Manager

BioLegend
San Diego, CA

Enabling Legendary Discovery: BioLegend develops world-class, cutting-edge antibodies and reagents for biomedical research, manufactured in our state-of-the-art facility in San Diego, CA. Our mission is to accelerate research and discovery by providing the highest quality products at an outstanding value, along with superior customer service and technical support.

Quality Assurance Manager: The Quality Assurance Manager will administer the quality management system (QMS) and will ensure that processes needed for QMS are effectively established, implemented and maintained, in accordance with applicable requirements and the Biolegend Vision and Mission. Some travel of less than 10% is required.

Essential Functions:

• Plan and manage the QMS, including processes and products, improvement of services, change control and risk management
• Create, review, and approve QMS documentation (DCRs, ECRS, CARs, ACARs, and other reports)
• Ensure that employees have access to the quality management system documentation
• Administer the Quality Manual and any associated procedures and documentation
• Assure products (current and new), materials and processes, including their applicable documentation, are complaint with applicable QMS requirements
• Assist with the determination of the applicable regulatory requirements that may have an impact on the Customer’s and other requirements
• Prepare the reviews of QMS to ensure compliance with applicable standards (such as ISO 9001, ISO 13485) and regulatory requirements.
• Report to the executive team on patterns, trends and other quantifiable measurements to ascertain the maintenance and effectiveness of the quality management system to meet the company’s Quality Policy, objectives and the requirements of customers
• Administer the audit program by supporting, hosting, and leading customer, supplier and regulatory audits.
• Work with management to ensure that the principles of quality and compliance are included in the company’s culture and that uniform quality practices are shared and trained in accordance with best practices in the industry.
• Recommend and initiate non-conforming activities, corrective and preventive action, root cause analysis, process improvement and complete resolution towards customer requests, customer feedback, inspections, audits, deviations and other related issues and will have the organizational freedom and authority to resolve all quality related issues, as necessary
• Liaison with interested parties, ensuring that customers and applicable regulatory authorities have appropriate access to the Quality System documentation
• Manage effective process validation and execution of manufacturing processes, test methods and facilities/ equipment
• Manage the QMS training program, including ISO 9001, ISO13485, and regulatory requirements, and act as a resource to ensure quality compliance
• Responsible for creation of executive reports for QA/ RA, including detailed analysis

Qualifications
Education

• Masters or better in Biology or related field.

Experience

• 10 years of relevant experience, preferably in a similar industry
• Experience with implementation and administration of Quality Assurance metrics, such as Non-Conformance, Corrective Actions in order monitor product performance
• Experience in managing and working with department team members
• Knowledge of ISO9001, ISO13485 and regulatory requirements for Life Science/Immunology production industry

Interested candidates should send their applications or resumes directly to our website at http://www.biolegend.com/careers

Contact us at swalsh@biolegend.com with any questions